EUCTR2009-014417-27-DK进行中（未招募）不适用
Randomised, double-blind, double-dummy, placebo-controlled, 4-way cross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL 5µg and 10µg (oral inhalation, delivered by the Respimat® Inhaler) and tiotropium bromide 18µg (oral inhalation, delivered by the HandiHaler®) after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •provision of informed consent
- •diagnosis of chronic obstructive pulmonary disease
- •post-bronchodilator FEV1 < 80% of predicted normal and a post-bronchodilator FEV1 / FVC < 70% at Visit 1
- •Male or female patients, 40 years of age or older
- •smoker or ex-smokers with a smoking history of more than 10 pack years
- •ability to perform technically acceptable pulmonary function tests
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant disease other than COPD
- •Clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis
- •SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN
- •History of asthma
- •Following conditions:diagnosis of thyrotoxicosis, diagnosis of paroxysmal tachycardia (>100 beats per minute), a history of myocardial infarction within 1 year of screening visit (Visit 1), unstable or life-threatening cardiac arrhythmia. hospitalization for heart failure within the past year, known active tuberculosis, a malignancy (resection, radiation therapy or chemotherapy within last five years; treated basal cell carcinoma accepted), history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis and history of significant alcohol or drug abuse
- •Undergone thoracotomy with pulmonary resection
- •Following concomitant medications: oral ß-adrenergics, oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, regularly use daytime oxygen therapy for more than one hour per day, completed pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or current pulmonary rehabilitation program, treatment with investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- •Known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the medications
- •Pregnant or nursing women
- •Women of childbearing potential not using two effective methods of birth control
研究者
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